Generic rival to Copaxone possible from next week

A 30-month stay of approval expires, but Teva does not see immediate competition.

A 30-month period stay of approval expires next week, marking the theoretical possibility of a launch of generic versions of Copaxone, Teva Pharmaceutical Industries Ltd's (Nasdaq: TEVA; TASE: TEVA) multiple sclerosis treatment. Copaxone, Teva's ethical drug, has more than $3 billion in annual sales, accounting for a third of the company's profit. Generic versions of the drug will slash the price and erode Copaxone's market share.

Under US law, when a generic drug company challenges a patent on an original drug, the drug's manufacturer has the right to sue for a 30-month period stay of approval for marketing the generic versions, unless a court rules in favor of the generic company before the expiry of the stay of approval.

In the summer of 2008, Teva sued Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ) subsidiary Sandoz AG and Momenta Pharmaceuticals Inc. (Nasdaq: MNTA) when they announced plans to develop a generic version of Copaxone. The 30-month stay of approval expires on January 16.

However, there is little likelihood of a generic version of Copaxone reaching the market at this time. The main barrier to generic Copaxone launch is not legal, but a decision by the US Food and Drug Administration (FDA) that the companies must conduct more tests on generic Copaxone.

Teva claims that Copaxone is difficult to replicate, and that there is no way to produce a generic version and obtain approval for it without conducting clinical trials. At a Goldman Sachs conference on Friday, Teva Americas CEO William Marth said that the company does not expect any generic competition to Copaxone anytime soon.

Teva's share price rose 3.3% by mid-afternoon on the TASE today to NIS 192.30, after rising 1.1% on Nasdaq on Friday to $54.01, giving a market cap of $50.55 billion.